The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)

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This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod (0.6 mg/d or 1.2 mg/d) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

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Ages Eligible for Study:

18 Years to 55 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.

Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.

Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.

Subjects must have disease duration of not more than 15 years.

Women of child-bearing potential (for example women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication o Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Subjects with progressive forms of MS.

Subjects with Neuromyelitis Optica (NMO).

Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to randomization.

Use of immunosuppressive agents,or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization.

Use of either of the following within 2 years prior to screening visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.

Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.